Altimmune Announces Third Quarter 2018 Financial Results and Provides Corporate Update
November 13 2018 - 4:50PM
Altimmune, Inc. (Nasdaq: ALT), a clinical-stage immunotherapeutics
company, today announced financial results for the three and nine
months ended September 30, 2018.
Recent Corporate Highlights
- Raised gross proceeds of $41.9 million in equity funding
through October 10, 2018. After deducting the underwriter discount,
placement agent fees, and other offering expenses the Company
received net proceeds of approximately $37 million.
- Announced additional positive data from its Phase 2a clinical
study of its NasoVAX intranasal influenza vaccine candidate.
The new data showed that serum antibody levels for NasoVAX
were stable over a six-month time period when compared to Fluzone’s
antibody levels, which declined by over 50% during the same time
period. Additionally, a significant mucosal immune response was
observed one month after vaccination when compared to both placebo
and Fluzone®. As in the prior clinical studies, NasoVAX again
had a clean safety profile. The Company previously announced
positive results from the study in 60 healthy individuals, which
demonstrated NasoVAX to be well-tolerated at all doses and showed
100% seroprotection at the two highest dose levels.
Additionally, NasoVAX demonstrated the ability to elicit a
significant T cell immune response as compared to Fluzone.
These new data identify another potentially important type of
immunity induced by NasoVAX and indicate that NasoVAX may have a
higher likelihood of protection throughout the entire flu
season.
- Received an award of $2.5 million in additional BARDA funding
to support NasoShield development. The funding is intended to
allow vaccine characterization including key formulation parameters
and batch consistency. Additionally, Altimmune will assay
clinical samples from its ongoing Phase 1 clinical trial for
mucosal immune response and compare different methods of
administration in preclinical models.
- Announced initial single-dose data from its Phase 1 study of
NasoShield, an anthrax vaccine candidate. This portion of the
ongoing study assessed the safety and immunogenicity of a single
intranasal dose of NasoShield in four dose cohort levels and showed
NasoShield to be safe and well-tolerated with no serious adverse
events. The immunogenicity data suggest that NasoShield may require
more than one dose for a robust immune response. The program
is funded through a contract with the Biomedical Advanced Research
and Development Authority (“BARDA”) which runs through September
2021 and, if all options are exercised, is expected to provide
funding through the end of Phase 2 development. Immunogenicity data
for the two-dose cohort will be available in the fourth quarter of
2018.
“The proceeds provided by our recent financings
will allow us to invest significantly in the development of NasoVAX
and to support our Company going forward,” said William J. Enright,
Chief Executive Officer of Altimmune. “Our developing pipeline and
novel approaches to vaccines are quite differentiated from other
approaches making these large markets attractive opportunities for
Altimmune.”
Third Quarter 2018 Financial
Highlights
- During the quarter the Company received $4.3 million of net
proceeds from a registered direct offering which brought September
30, 2018 cash on hand to approximately $8.0 million.
- Subsequent to quarter end, the Company received additional net
proceeds of approximately $32.7 million related to its October 2
Underwritten Public Offering and October 10 Registered Direct
Offering.
- Third quarter revenue was $2.6 million compared to $4.6 million
in the prior year period. Revenue fluctuated in proportion to
our research and development expenses for the NasoShield and
SparVax-L programs.
- Research and development expenses were $4.7 million compared to
$5.9 million in the prior year period. The decrease is
primarily attributable to lower spending on NasoShield
manufacturing when compared to the same period in 2017.
- General and administrative expenses were $2.0 million as
compared with $3.0 million for the same period in 2017. The
decrease is primarily attributable to 2017 professional services
related to the integration of the newly merged entity that did not
recur in 2018.
- Other Income (expense) was $0.9 million compared to ($0.5)
million for the same period in 2017. The change was primarily
due to the release of warrant liability associated with warrant
exchanges consummated during the quarter.
- Net loss attributed to common stockholders was $2.3 million
compared to $31.9 million for the same period in 2017. The
increase was due primarily to $26.6 million goodwill impairment in
2017 in addition to the activity described above.
About AltimmuneAltimmune is a
clinical-stage immunotherapeutics company focused on the
development of products to stimulate robust and durable immune
responses for the prevention and treatment of disease and on the
development of two next-generation anthrax vaccines that are
intended to improve protection and safety while having favorable
dosage and storage requirements compared to other anthrax vaccines.
The company has two proprietary platform technologies, RespirVec
and Densigen, each of which has been shown to activate the immune
system in distinctly different ways than traditional vaccines.
Forward-Looking Statement Any statements
made in this press release relating to future financial or business
performance, conditions, plans, prospects, trends, or strategies
and other financial and business matters, including without
limitation, the prospects for commercializing or selling any
product or drug candidates, are forward-looking statements within
the meaning of the Private Securities Litigation Reform Act of
1995. In addition, when or if used in this press release, the words
“may,” “could,” “should,” “anticipate,” “believe,” “estimate,”
“expect,” “intend,” “plan,” “predict” and similar expressions and
their variants, as they relate to Altimmune, Inc. (the
“Company”) may identify forward-looking statements. The Company
cautions that these forward-looking statements are subject to
numerous assumptions, risks, and uncertainties, which change over
time. Important factors that may cause actual results to differ
materially from the results discussed in the forward looking
statements or historical experience include risks and
uncertainties, including risks relating to: the terms of the
Company’s Series B preferred stock offering and related warrants;
our lack of financial resources and access to capital; realizing
the benefits of the merger between Altimmune,
Inc. and PharmAthene, Inc.; our ability to utilize the
benefits of our tax assets and the results of a tax examination
initiated by the IRS; clinical trials and the commercialization of
proposed product candidates (such as marketing, regulatory, product
liability, supply, competition, dependence on third parties and
other risks); the regulatory approval process; dependence on
intellectual property; the Company’s BARDA contract and other
government programs, reimbursement and regulation. Further
information on the factors and risks that could affect the
Company's business, financial conditions and results of operations
are contained in the Company’s filings with the U.S.
Securities and Exchange Commission, including under the heading
“Risk Factors” in the Company’s annual reports on Form 10-K and
quarterly reports on Form 10-Q filed with the SEC, which are
available at www.sec.gov.
ContactsBill Enright
President
and CEO
Phone:
240-654-1450
Ashley R. RobinsonManaging Director LifeSci AdvisorsPhone:
617-535-7742
|
|
ALTIMMUNE, INC. |
UNAUDITED CONDENSED CONSOLIDATED STATEMENTS OF
OPERATIONS |
AND COMPREHENSIVE LOSS |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Three Months Ended
September 30, |
|
Nine Months Ended
September 30, |
|
|
2018 |
|
2017 |
|
2018 |
|
2017 |
Revenue |
|
|
|
|
|
|
|
|
|
|
|
|
Research grants and
contracts |
|
$ |
2,629,446 |
|
|
$ |
4,565,251 |
|
|
$ |
7,727,681 |
|
|
$ |
7,892,919 |
|
License revenue |
|
|
4,947 |
|
|
|
26,689 |
|
|
|
14,833 |
|
|
|
36,565 |
|
Total
revenue |
|
|
2,634,393 |
|
|
|
4,591,940 |
|
|
|
7,742,514 |
|
|
|
7,929,484 |
|
Operating expenses |
|
|
|
|
|
|
|
|
|
|
|
|
Research
and development |
|
|
4,728,726 |
|
|
|
5,905,552 |
|
|
|
15,394,616 |
|
|
|
13,946,403 |
|
General
and administrative |
|
|
1,963,733 |
|
|
|
3,038,756 |
|
|
|
7,345,651 |
|
|
|
6,863,782 |
|
Goodwill
impairment charges |
|
|
— |
|
|
|
26,600,000 |
|
|
|
490,676 |
|
|
|
26,600,000 |
|
Total
operating expenses |
|
|
6,692,459 |
|
|
|
35,544,308 |
|
|
|
23,230,943 |
|
|
|
47,410,185 |
|
Loss from
operations |
|
|
(4,058,066 |
) |
|
|
(30,952,368 |
) |
|
|
(15,488,429 |
) |
|
|
(39,480,701 |
) |
Other income
(expense): |
|
|
|
|
|
|
|
|
|
|
|
|
Changes
in fair value of warrant liability, including gain (loss) on
exchange |
|
|
806,224 |
|
|
|
(508,316 |
) |
|
|
(2,874,484 |
) |
|
|
(508,316 |
) |
Changes
in fair value of embedded derivatives |
|
|
185,768 |
|
|
|
(1,157 |
) |
|
|
183,638 |
|
|
|
(1,157 |
) |
Interest
expense |
|
|
(166,946 |
) |
|
|
(2,344 |
) |
|
|
(169,737 |
) |
|
|
(160,103 |
) |
Interest
income |
|
|
21,100 |
|
|
|
15,372 |
|
|
|
78,306 |
|
|
|
19,538 |
|
Other
income (expense) |
|
|
31,378 |
|
|
|
10786 |
|
|
|
289,053 |
|
|
|
9,839 |
|
Total
other income (expense) |
|
|
877,524 |
|
|
|
(485,659 |
) |
|
|
(2,493,224 |
) |
|
|
(640,199 |
) |
Net loss before income
tax benefit |
|
|
(3,180,542 |
) |
|
|
(31,438,027 |
) |
|
|
(17,981,653 |
) |
|
|
(40,120,900 |
) |
Income tax benefit |
|
|
829,393 |
|
|
|
1,532,790 |
|
|
|
3,318,124 |
|
|
|
2,526,499 |
|
Net loss |
|
|
(2,351,149 |
) |
|
|
(29,905,237 |
) |
|
|
(14,663,529 |
) |
|
|
(37,594,401 |
) |
Other comprehensive
income (loss) – foreign currency translation adjustments |
|
|
— |
|
|
|
(1,028,033 |
) |
|
|
(463,177 |
) |
|
|
(2,864,839 |
) |
Comprehensive loss |
|
$ |
(2,351,149 |
) |
|
$ |
(30,933,270 |
) |
|
$ |
(15,126,706 |
) |
|
$ |
(40,459,240 |
) |
Net loss |
|
$ |
(2,351,149 |
) |
|
$ |
(29,905,237 |
) |
|
$ |
(14,663,529 |
) |
|
$ |
(37,594,401 |
) |
Preferred stock
accretion, contributions, and dividends |
|
|
64,139 |
|
|
|
(1,962,072 |
) |
|
|
(2,527,275 |
) |
|
|
(2,125,141 |
) |
Net loss attributed to
common stockholders |
|
$ |
(2,287,010 |
) |
|
$ |
(31,867,309 |
) |
|
$ |
(17,190,804 |
) |
|
$ |
(39,719,542 |
) |
Weighted-average common
shares outstanding, basic and diluted |
|
|
1,321,289 |
|
|
|
517,596 |
|
|
|
983,651 |
|
|
|
386,524 |
|
Net loss per share
attributed to common stockholders, basic and diluted |
|
$ |
(1.73 |
) |
|
$ |
(61.57 |
) |
|
$ |
(17.48 |
) |
|
$ |
(102.76 |
) |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
ALTIMMUNE, INC. |
UNAUDITED CONDENSED CONSOLIDATED BALANCE
SHEETS |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
September 30, |
|
December 31, |
|
2018 |
2017 |
ASSETS |
|
|
|
|
|
|
|
|
Current assets: |
|
|
|
|
|
|
|
|
Cash and
cash equivalents |
|
$ |
7,964,002 |
|
|
$ |
8,769,465 |
|
Restricted cash |
|
|
34,174 |
|
|
|
3,534,174 |
|
Total
cash, cash equivalents and restricted cash |
|
|
7,998,176 |
|
|
|
12,303,639 |
|
Accounts
receivable |
|
|
2,547,402 |
|
|
|
3,806,239 |
|
Tax
refund receivable |
|
|
976,523 |
|
|
|
6,361,657 |
|
Prepaid
expenses and other current assets |
|
|
443,929 |
|
|
|
994,332 |
|
Total
current assets |
|
|
11,966,030 |
|
|
|
23,465,867 |
|
Property and equipment,
net |
|
|
1,407,080 |
|
|
|
603,146 |
|
Intangible assets,
net |
|
|
38,339,086 |
|
|
|
38,722,270 |
|
Other assets |
|
|
1,149,185 |
|
|
|
238,917 |
|
Total
assets |
|
$ |
52,861,381 |
|
|
$ |
63,030,200 |
|
LIABILITIES, REDEEMABLE CONVERTIBLE PREFERRED STOCK AND
STOCKHOLDERS’ EQUITY |
|
|
|
|
|
|
|
|
Current
liabilities: |
|
|
|
|
|
|
Notes
payable |
|
$ |
1,467,260 |
|
|
$ |
49,702 |
|
Accounts
payable |
|
|
150,738 |
|
|
|
129,075 |
|
Accrued
expenses and other current liabilities |
|
|
6,532,924 |
|
|
|
3,625,257 |
|
Current
portion of deferred revenue |
|
|
19,753 |
|
|
|
19,753 |
|
Current
portion of deferred rent |
|
|
173,952 |
|
|
|
15,914 |
|
Total
current liabilities |
|
|
8,344,627 |
|
|
|
3,839,701 |
|
Deferred income
taxes |
|
|
2,891,634 |
|
|
|
5,938,402 |
|
Other long-term
liabilities |
|
|
1,941,932 |
|
|
|
4,574,507 |
|
Total
liabilities |
|
|
13,178,193 |
|
|
|
14,352,610 |
|
Contingencies
(Note 16) |
|
|
|
|
|
|
Series B
redeemable convertible preferred stock; $0.0001 par value;
16,000 shares designated; 0 and 12,177 shares issued and
outstanding at September 30, 2018 and December 31, 2017,
respectively. |
|
|
— |
|
|
|
9,281,767 |
|
Stockholders’
equity: |
|
|
|
|
|
|
Common
stock, $0.0001 par value; 200,000,000 and 100,000,000 shares
authorized; 1,726,198 and 609,280 shares issued; 1,725,630 and
608,499 shares outstanding at September 30, 2018 and
December 31, 2017, respectively |
|
|
173 |
|
|
|
61 |
|
Additional paid-in capital |
|
|
137,071,546 |
|
|
|
121,657,587 |
|
Accumulated deficit |
|
|
(92,348,368 |
) |
|
|
(77,684,839 |
) |
Accumulated other comprehensive loss – foreign currency translation
adjustments |
|
|
(5,040,163 |
) |
|
|
(4,576,986 |
) |
Total
stockholders’ equity |
|
|
39,683,188 |
|
|
|
39,395,823 |
|
Total
liabilities and stockholders’ equity |
|
$ |
52,861,381 |
|
|
$ |
63,030,200 |
|
|
|
|
|
|
|
|
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